Phase 2
Completed N=190
Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma
Source: ClinicalTrials.gov NCT00766090 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period — 2.605; 2.714; 2.703; 2.693 Liters — p=<0.001
Summary
The purpose of this study is to compare once and twice daily GW685698 in asthma
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period |
2.605; 2.714; 2.703; 2.693; 2.737 | <0.001 sig |
| SECONDARY Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods |
26; 22; 26; 2; 3; 0 | — |
| SECONDARY 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period |
53.94; 40.25; 45.13; 56.16; 47.56 | — |
| SECONDARY Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period |
0; 0; 0; 0; 0; 187 | — |
| SECONDARY Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period |
120.1; 118.3; 119.5; 122.1; 121.3; 119.6 | — |
| SECONDARY Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period |
77.0; 76.4; 77.6; 74.5; 75.8; 76.6 | — |
| SECONDARY Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods |
5; 1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Clinical diagnosis of Asthma
- Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
- FEV1 between 40-85% predicted
- Currently on short acting beta2 agonist therapy
Key Exclusion Criteria
- History of life threatening asthma
- Respiratory Infection or oropharyngeal candidiasis
- Asthma exacerbation
- Uncontrolled disease or clinical abnormality
- Allergies
- Taking another Investigational medications or other prohibited medications
Data sourced from ClinicalTrials.gov (NCT00766090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.